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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68741

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
June 24, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Brainlab AG

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

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Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

ExacTrac is intended to be used to place patients at an accurately defined point within the treatment beam of a medical accelerator for stereotactic radiosurgery or radiotherapy procedures, in order to treat lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. ExacTrac may also be used to monitor the patient position during the treatment.

Z-2146-2014
Recall number
Z-2146-2014
Initiated
June 24, 2014
Classification
Class II
Status
Terminated
Recalling firm
Brainlab AG
Quantity
15 systems

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
When using multiple isocenters (radiation treatment targets) within a single plan, in certain workflow conditions ExacTrac v.6.0.4 might move the patient to an unintended isocenter position, despite displaying the green "OK" icon. If this anomaly occurs and is not detected by the user, the radiation treatment dose at the linear accelerator may be delivered to the unintended target position.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

When using multiple isocenters (radiation treatment targets) within a single plan, in certain workflow conditions ExacTrac v.6.0.4 might move the patient to an unintended isocenter position, despite displaying the green "OK" icon. If this anomaly occurs and is not detected by the user, the radiation treatment dose at the linear accelerator may be delivered to the unintended target position.

Code information

ExacTrac Version 6.0.4; Model/Catalog Numbers: 1) 20833C EXACTRAC 6.0 IR POSITIONING SOFTWARE; 2) 20834C EXACTRAC 6.0 X-RAY POSITIONING SOFTWARE; 3) 20835C EXACTRAC 6.0 IR MONITORING SOFTWARE; 4) 20853C EXACTRAC 6.0 X-RAY LIMITED SOFTWARE; 5) 49926B ET UPGRADE SOFTWARE 3.X TO 6.0 (IR+XR); 6) 49927B ET UPGRADE SOFTWARE 4.X TO 6.0 (IR+XR); 7) 49928B ET UPGRADE SOFTWARE 5.X TO 6.0 (IR+XR); 8) 49933B ET UPGRADE TRUEBEAM 5.5 TO 6.0 LIMITED; 9) 49934A EXACTRAC UPGRADE 5.5 TO 6.0 BASIC; 10) 49936A ET SOFTWARE UPDATE 6.0.X TO 6.0.4; 11) 49938 ET SOFTWARE UPDATE 6.0.3TO 6.0.4; 12) 49939 ET SOFTWARE UPDATE 6.0.X to 6.0.4 P&R; 13) 49973B ET DATA PREP / REVIEW SYSTEM; 14) 49996B ET UPGRADE SOFTWARE X.X TO 6.0 SW ONLY; 15) 49997B ET UPGRADE SOFTWARE 5.5 TO 6.0 LIMITED; 16) 49998B ET 6.0 DATA PREP/REVIEW SYSTEM UPG. KIT

Distribution pattern

Worldwide Distribution - USA including CA, CT, and IL; Internationally to France, Germany, Japan, Netherlands, Russia, and Slovenia.